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| Dockets Entered
On June 15, 2006
Table of Contents
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| Docket #
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| Title
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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| 2001D-0269
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| Clinical Studies Section for Prescription Drugs & Biologics
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| 2003N-0355
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| Medical Devices; Exception from General Requirements for Informed Consent
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| 2005D-0199
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
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| 2005D-0200
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| 2006E-0250
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| Patent Extension Application for SOLTAMOX (tamoxifen citrate for oral administration), U.S. Patent No. 6,127,425
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| 2006F-0225
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| Filing of Food Additive Petition (FAP 6A4765) to amend the food additive regulations in 172.735 Glycerol ester of wood or gum rosin (21 CFR 172.735)
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| 2006N-0109
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| General and Plastic Surgery Devices; Reclassification of the Topical Oxygen Chamber for Extremities
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| 2006N-0181
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| Product Stability Data: Notice of Pilot Project
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| 2006P-0249
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| Refain from approving all abbreviated applications for generic enrofloxacin that purport to copy Bayer's Baytril 100 Injectable Solution
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| 2006V-0248
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| Laser Light Show
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| 1981N-0033
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| Oral Health Care Drug Products for OTC Human Use
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| EC 1
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| Mrs. Sandra Swayze
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| Vol #:
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| 72
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| EC 2
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| Consumer Healthcare Products Association
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| Vol #:
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| 72
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| 2000D-1306
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| Content & Format of the Adverse Reactions Section of Labeling
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| EC 7
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| Dr. Stephen Sack
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| Vol #:
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| 1
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| 2001D-0269
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| Clinical Studies Section for Prescription Drugs & Biologics
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| EC 1
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| Dr. Stephen Sack
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| Vol #:
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| 1
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| 2003N-0355
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| Medical Devices; Exception from General Requirements for Informed Consent
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| EC 1
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| Ms. Amy Todisco
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| Vol #:
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| 1
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| EC 2
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| Mrs. R Thomas
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| Vol #:
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| 1
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| EC 3
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| Mr. Steven White DTR
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| Vol #:
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| 1
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| EC 4
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| Mr. Shirley Isbill
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| Vol #:
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| 1
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| 2005D-0199
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| 2005D-0200
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| International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Accep
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| GDL 2
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| Guidance
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| Vol #:
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| 1
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| 2005D-0483
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| Guidance for Industry and Food and Drug Administration: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006
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| EC 9
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| Mr. Randal South
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| Vol #:
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| 1
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| MO 12
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| TMJ Implants, Inc., and Robert W. Christensen and Maureen K Mooney
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| Vol #:
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| 3
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| RMO 4
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| FDA/CDRH/OGC
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| Vol #:
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| 3
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| RMO 5
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| TMJ Implants, Inc., and Robert W. Christensen and Maureen K Mooney
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| Vol #:
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| 3
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 12825
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| Unreadable
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| Vol #:
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| 153
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| C 12826
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| S. Fankal
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| Vol #:
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| 153
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| C 12827
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| T. Quina
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| Vol #:
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| 153
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| C 12828
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| L. Hickley
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| Vol #:
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| 153
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| C 12829
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| unreadable
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| Vol #:
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| 153
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| C 12830
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| L. Thompson
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| Vol #:
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| 153
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| C 12831
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| L. Koellman
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| Vol #:
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| 153
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| C 12832
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| C. DiBiaggio
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| Vol #:
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| 153
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| C 12833
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| T. Kiro
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| Vol #:
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| 153
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| C 12834
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| C. Wimen
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| Vol #:
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| 153
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| C 12835
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| illegible
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| Vol #:
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| 153
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| C 12836
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| E. Crutzher
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| Vol #:
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| 153
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| C 12837
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| L. Feundl
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| Vol #:
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| 153
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| C 12838
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| illegible
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| Vol #:
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| 153
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| C 12839
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| H. Hendricks
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| Vol #:
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| 153
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| C 12840
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| D. Arman
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| Vol #:
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| 153
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| C 12841
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| A. MacAulay
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| Vol #:
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| 153
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| C 12842
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| C. E. Contey, M.D.
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| Vol #:
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| 153
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| C 12843
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| B. Roberts
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| Vol #:
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| 153
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| C 12844
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| I. Arnold
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| Vol #:
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| 153
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| C 12845
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| J. A. Levin
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| Vol #:
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| 153
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| C 12846
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| J. Rosini
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| Vol #:
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| 153
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| C 12847
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| S. Ollice
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| Vol #:
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| 153
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| C 12848
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| B. Kistler
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| Vol #:
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| 153
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| C 12886
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| A. Brooks
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| Vol #:
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| 153
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| C 12887
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| L. J. Allen
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| Vol #:
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| 153
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| C 12888
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| J. K. Ruyts
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| Vol #:
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| 153
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| C 12889
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| C. Carlucci
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| Vol #:
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| 153
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| C 12890
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| R. Courey
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| Vol #:
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| 153
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| C 12891
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| S. Biondolillo
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| Vol #:
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| 153
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| C 12892
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| B. W. Zuckerman
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| Vol #:
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| 153
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| C 12893
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| R. M. Zuckerman
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| Vol #:
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| 153
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| C 12894
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| M. M. Monti
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| Vol #:
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| 153
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| C 12895
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| T. Zuluaga
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| Vol #:
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| 153
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| C 12896
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| L. K. Rider
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| Vol #:
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| 153
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| C 12897
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| O. De Long
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| Vol #:
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| 153
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| C 12898
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| N. Mooring
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| Vol #:
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| 153
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| C 12899
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| L. de Nuccio
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| Vol #:
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| 153
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| C 12900
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| J. Baptista
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| Vol #:
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| 153
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| C 12901
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| T. Callaris
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| Vol #:
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| 153
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| C 12902
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| P. Pierce
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| Vol #:
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| 153
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| C 12903
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| S. Nichols
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| Vol #:
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| 153
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| C 12904
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| C. Culla
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| Vol #:
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| 153
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| C 12905
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| M. Ackermann
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| Vol #:
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| 153
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| C 12906
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| B. Johnson
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| Vol #:
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| 153
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| 2005P-0459
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| To enforce ban on carbon monoxide gas in fresh meat packaging
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| LET 1
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| Kalsec Inc.
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| Vol #:
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| 4
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| RC 2
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| Kalsec Inc.
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| Vol #:
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| 4
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| SUP 1
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| Kalsec Inc.
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| Vol #:
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| 5
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| 2006E-0250
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| Patent Extension Application for SOLTAMOX (tamoxifen citrate for oral administration), U.S. Patent No. 6,127,425
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| APP 1
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| Savient Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| LET 1
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| U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006F-0225
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| Filing of Food Additive Petition (FAP 6A4765) to amend the food additive regulations in 172.735 Glycerol ester of wood or gum rosin (21 CFR 172.735)
|
|
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| NFL 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0065
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| Emerging Clostridial Disease; Public Workshop
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| EC 2
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| Weill Medical College of Cornell University
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| Vol #:
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| 2
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| EC 3
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| GermGard Lighting LLC
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| Vol #:
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| 2
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| EC 4
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| The University of Arizona
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| Vol #:
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| 2
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